A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Launched by ABBVIE · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called venetoclax when combined with two other treatments, obinutuzumab and acalabrutinib, for adults with chronic lymphocytic leukemia (CLL), a type of blood cancer. The goal is to find out if this combination can help treat CLL while also keeping an eye on potential side effects, particularly a condition known as Tumor Lysis Syndrome (TLS). About 120 adults who have not yet received treatment for CLL will participate in the study, which will last for approximately 28 months.

To be eligible for this trial, participants must be diagnosed with untreated CLL and have a life expectancy of more than six months. They should also be in generally good health, able to perform regular daily activities, and have certain blood and kidney function levels. Participants can expect to visit a hospital or clinic regularly for assessments, blood tests, and to report any side effects they might experience. While this trial may involve more visits and treatments than standard care, it aims to provide valuable information that could help improve future treatments for CLL.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of \> 6 months.
• • Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation.
• • Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
• • Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol.
• • Creatinine clearance (CrCl) \>= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion.
• Exclusion Criteria:
• • - Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.

Trial Officials